Rheumatism and rheumatoid arthritis (RA) are generally considered to be difficult-to-treat diseases. Approximately 18 million RA patients are disabled by the disease. Research into new medications to treat RA has already been underway for almost a century. Aspirin was the earliest medication widely used for RA. Medications to treat RA may be generally divided into two types: non-steroidal anti-inflammatory drugs (NSAIDs) and immunosuppressants. NSAIDs include diclofenac and other anti-inflammatories and adrenal cortical hormones. Clinical studies demonstrate that NSAIDs are effective. Immunosuppressants and cytotoxic medications include methotrexate, cyclophosphamide, and penicillamine, among others. In recent years, immunomodulation has been used as a method for treating rheumatic diseases. All anti-rheumatism drugs have been shown to have serious side effects and to date, a high-efficacy, low-toxicity medication has not yet been developed.
There are three main areas of emphasis in the research and development of anti-rheumatism drugs. The first includes NSAIDs and cytokine antagonists, such as recombinant soluble tumor necrosis factor antagonists, interleukin-1 receptor antagonists and platelet activation factor inhibitors. The second area is new immunosuppressants or immunomodulators, such as cyclosporin A. The third area is compound medications.
Early treatment of bi syndrome (obstruction of qi and blood, RA) in the field of traditional Chinese medicine can be dated to the ancient Chinese physician Zhang Zhongjing, “decoction of herba ephedrae, semen armeniacae amarum, gypsum fibrosum and radix glycyrrhizae,” “decoction of radix stephaniae tetrandrae and radix astragali” and “decoction of radix aconite.” Kniphofia uvaria is a plant that grows wild in Sichuan Province, and in local area clinical trials (in Sichuan) it has been proven to have definite therapeutic efficacy for patients with rheumatism. Unfortunately, at the same time many uncontrollable problems and serious side effects on the human reproduction system have been observed.
In traditional Chinese medicine, there is a long history of treating bi syndrome, and in past eras, physicians have developed traditional Chinese medications to treat it. There are a number of medications with high therapeutic efficacy. In the 1995 and 2000 editions of the Chinese Pharmacopeia are collected no fewer than 80 single medications and 29 proprietary medications to treat bi syndrome. But there are problems, chiefly {circle around (1)} therapeutic efficacy against severe bi syndrome such as rheumatoid arthritis is still less than ideal, {circle around (2)} the preparation's dosage form cannot meet the needs of today's lifestyle, {circle around (3)} a small number of medications possess therapeutic efficacy that could be termed good yet with major toxic side effects, such as the Radix tripterygii wilfordii preparation. This necessitates research and development of an anti-rheumatism medication with high efficacy and low toxicity, in a dosage form suited to today's lifestyle and medication-use habits, in particular a medication with treatment efficacy that can approach the efficacy of synthetic anti-rheumatism medications and has relatively mild side effects.